{"analyses":[{"ciLowerLimit":"0.631","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.621","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.","pValue":"=0.963","paramType":"Hazard Ratio (HR)","paramValue":"1.011","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.62","upperLimit":"13.90","value":"9.6"},{"groupId":"OG001","lowerLimit":"6.01","upperLimit":"17.02","value":"10.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"74"}],"units":"Participants"}],"description":"High-risk population included but not be limited to participants carrying del17, t(4;14), t(14;16). PFS was defined as the time from the date of randomization to the date of first documentation of PD or death from any cause.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.","id":"OG000","title":"Placebo"},{"description":"Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.","id":"OG001","title":"Ixazomib"}],"paramType":"MEDIAN","populationDescription":"ITT Population included all participants who were randomized and had post-randomization data. Overall number of participants analyzed is the number of participants present in the high-risk group.","reportingStatus":"POSTED","timeFrame":"From randomization until PD or death (up to 52 months)","title":"PFS in a High-risk Population","type":"SECONDARY","unitOfMeasure":"months"}